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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bar Code Label Requirements for Blood and Blood Components

Judy Ellen Ciaraldi
BS, MT(ASCP)SBB, CQA(ASQ)
Consumer Safety Officer, DBA, OBRR, CBER
ACBSA, May 9-10, 2006


Before the Bar Code Rule

Old regulation (21 CFR 606.121(c)(13)):

Container label may bear encoded information in the form of machine readable symbols approved for use the Director, CBER

Why Require Bar Codes?

  • DHHS Secretary Thompson set up a Patient Safety Task Force in 2001
  • Bar codes allow healthcare professionals to use scanning equipment to verify right drug (blood component) is given to right patient
  • Reduce number of medicine and transfusion errors (502,000 in 20 years)
  • Save healthcare costs ($93 billion in 20 years)

Bar Code Label Rule

  • Now mandates machine readable information on label
  • Final Rule - February 26, 2004 (69 FR 9120)
  • Effective date - April 26, 2004
  • Dates for compliance:
    • Products approved after effective date - within 60 days of approval
    • Products approved before effective date - within 2 years of effective date (April 26, 2006), includes blood components

Applicable Regulations

  • 21 CFR 201.25 - Bar code label requirements
    • Applies to most prescription drugs and certain OTC drugs regulated under FD&C and PHS Acts
    • Minimum information in linear bar code - NDC number
    • Does not apply to hospitals, clinics or public health agencies
  • 21 CFR 610.17 - Bar code label requirements
    • Biological products must comply with 201.25
    • Does not apply to devices
    • Does not apply to blood and blood components for transfusion; these must comply with 606.121(c)(13)

Applicable Regulations

  • 21 CFR 606.121(c)(13) - Container label
    • Container label must bear encoded information in format that is machine readable and approved by Director, CBER
    • Applies to blood and blood components intended for transfusion regulated under FD&C and PHS Acts
    • Applies to all blood establishments that manufacture, process, repack or relabel blood and blood components, including hospital transfusion services that pool or aliquot blood components
    • Does not apply to Source Plasma

Which Products Must Comply?

  • Any blood component that can be transfused to a patient and blood components used to make the final transfusible blood component. Also includes:
    • Aliquots
    • Split or divided units
    • Syringes
    • Pooled units
  • Intraoperatively collected autologous blood that is stored in and dispensed from the blood bank
  • Fibrin/platelet sealant manufactured for allogeneic use

Which Products are Exempt?

  • Products for further manufacturing use - recovered plasma, Source Plasma, Source Leukocytes
  • Devices - e.g., filters, apheresis instruments, blood collection sets
  • Intraoperative autologous blood collected and transfused in OR or RR; includes salvaged autologous blood that stays with patient
  • Autologous fibrin/platelet sealant manufactured and used intra-operatively
  • Drainage collected in OR or ER as part of trauma care

Machine Readable Information

  • Unique facility identifier (e.g., FDA registration number)
  • Lot number (unit or bleed number) relating the unit to the donor
  • Product code
  • ABO and Rh of the donor

Bar Code Information Requirements

  • Must be on container label
  • Must be unique to the blood component
  • Must be surrounded by sufficient blank space so information can be scanned correctly
  • Must remain intact under normal conditions of use

Symbology

  • Machine readable vs. Bar code
  • Did not specify a particular machine readable symbology to accommodate for new bar codes and changes in technology
  • FDA recognized Codabar in 1985
  • FDA approved ISBT 128 (v.1.2.0) in 2000
    • Some issues not consistent with regulations, requires variance submission

Bar Code Rule for Tissues

  • Applies to human cells, tissues and cellular/tissue-based products subject to pre-market approval under Sec. 351 of PHS Act
  • Does not apply to hematopoietic stem/progenitgor cells from peripheral or cord blood only regulated under Sec. 361 of the PHS Act
    • Autologous
    • First and second degree blood relatives

Are Exceptions Allowed?

  • Not consider requests based on:
    • Financial reason
    • Claim that there is a low rate of error associated with product
  • We will review requests if complying with rule:
    • Affects safety, purity, potency and effectiveness of product
    • Not technically feasible

Information and Guidance

  • Final Rule: Bar Code Label Requirements for Human Drug Products and Biological Products (2/26/04)
    http://www.fda.gov/cber/rules/barcodelabel.htm
  • Frequently Asked Questions: Bar Code Label Requirements for Blood and Blood Components (4/7/06)
    http://www.fda.gov/cber/faq/barcodefaq.htm
  • Guidance for Industry: Bar Code Label Requirements: Questions and Answers (4/06)
    http://www.fda.gov/cber/gdlns/barcode.htm

Information and Guidance

  • Guideline for the Uniform Labeling of Blood and Blood Components (8/85)
    http://www.fda.gov/cber/guidelines.htm#95
  • Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components (6/6/00)
    http://www.fda.gov/cber/gdlns/unilabbld.htm
  • Manufacturers Assistance and Technical Training Branch of Office of Communication, Training and Manufacturers Assistance, CBER
    Email - matt@cber.fda.gov

 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002